China submits conditional application to join ICH

The China Food and Drug Administration (CFDA) and U.S.-based nonprofit, multidisciplinary association the Drug Information Association (DIA) recently held a joint seminar on International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) standards. The CFDA’s International Cooperation Secretary Yuan Lin revealed that China has submitted an application for conditional access to the ICH. China has been engaged with exchanges in relation to amending ICH standards, and has already adopted around 20 such standards, including Good Clinical Practice (GCP) norms.

Also speaking at this week’s event, Dr. Theresa Mullin, Director of the Strategic Planning Office of the U.S. FDA's Center for Drug Evaluation and Research, and Dr. Barbara Kunz, DIA Global CEO, and director of the International Project Office of the Japanese Medicines and Devices Supervision Board, outlined coming ICH reforms, and the contribution of the DIA to ICH's global development. ICH is planning to expand its existing membership to involve more regulators around the world. The CFDA’s recent feedback documents in relation to drug approval norms revealed plans to move much more closely in synch with ICH norms, with the promise of synchronized European/U.S. development in future.